11/13/2019 Drug Importation Stakeholder Update Senate Bill 19-005 Presented by: Kelly Swartzendruber , PharmD, Drug Importation, Health Care Policy & Finance 1 Agenda • Why Drug Importation? • Legislative Framework for Drug Importation • Importation timeline • Program Feedback Process and Actions Taken • Overview of the Process • Key Proposal points o Program Costs/ Profits o Consumer S avings o Quality and S afety • Key Questions for stakeholders • Next steps • Final Questions 2 1
11/13/2019 Why Drug Importation? 3 Legislative Framework for Drug Importation Federal Food Drug and Cosmetic Act (FDCA) • S ection 804 permits importation and reimportation of prescription drugs from Canada by a pharmacist or wholesaler, provided the drugs meet certain minimum standards. The Program must: o Pose no additional risk to the public’ s health and safety o Results in a significant reduction in costs to consumers o HHS must certify/ approve a program to proceed Senate Bill 19-005 Identify and contract with one/ more vendors to develop a drug list, identify/ facilitate contracts with participating suppliers and importers that meet safety and quality requirements and conduct safety assurance measures and other oversight processes Several States looking at this: • Colorado, Florida, Maine, Vermont, Utah 4 2
11/13/2019 Importation Project Timeline 5 Process overview Program Framework • ○ Positive consumer impact ○ Ensures safety HCPF Oversight • ○ Division of Drug Importation within Pharmacy Office ○ Drug List development, profit margins, program costs ○ Ultimate responsibility for the program ○ Vendor contract ■ Program Oversight ■ RFP Process 6 3
11/13/2019 Overview of the Process Importer or importers • Patients could receive • CAN drugs from a choice of pharmacies 7 Key Proposal Points: Program Costs/Profits • S B19-005 Requirements: ○ Profit margin on imported drugs can’ t be more than profit margin of the US versions of the same drugs ○ Program costs can include a fee but that fee can’ t significantly reduce consumer savings • S upply chain mark-up of 45% (from Canadian acquisition costs) ○ Repackaging/ Relabeling ○ Testing ○ Records/ Recall Management/ Profit to supply chain ■ Wholesalers ■ Pharmacies 8 4
11/13/2019 Key Proposal Points: Consumer Savings Drug List Details • Excluded drugs from Importation include: Generic products that would violate U.S . patent laws o Controlled substances o Biologics (will include insulin starting in March 2020) o Infused drugs o Intravenously inj ected drugs o Drugs inhaled during surgery o Parenteral drug o • S uggested drugs types for importation include: High cost brand name drugs o High volume drugs o Drugs with US shortages o 9 Key Proposal Points: Consumer Savings Drug List Details, Cont. • Initial Drug List Parameters ○ Total cost of the drug (copay and plan) ■ Total charge for ages 19-64 ○ Total member liability (all ages) ○ Volume of Prescriptions number of patients ○ Patent law rules Drug List Examples - DRAFT • ○ Asthma (Breo Ellipta, Dulera, Advair Diskus, Ventolin HFA) ○ HIV (Atripla, Triumeq, Truvada) ○ Epi-Pen & Epi-Pen Jr. ○ Hormones (Estring, Premarin Cream, S ynthroid) ○ Misc.: Invokana, Ibrance, Gilenya 10 5
11/13/2019 Key Proposal Points: Quality & Safety Program Requirements Compliance with DS CS A • ○ Track and Trace requirements from manufact urer to dispenser of the medication ○ Requires serialization once enacted Private Label Distributor Concept • ○ S tate of Colorado to become a Private Label Distributor No manufacturing/ processing o Markets and Distributes under it’ s own trade name o Labels drug to be compliant with FDA requirements o Can be state OR a contractor hired by the state o 11 Key Proposal Points: Quality & Safety, Cont. Private Label Distributor 12 6
11/13/2019 Next Steps: Drug Importation • Collate feedback • Use feedback to add detail to the program at all levels • Create Initial Application to HHS ○ S end to HHS by 1/ 15/ 20 • For more information: ○ https:/ / www.colorado.gov/ hcpf/ drug-importation In-box for questions ■ S ign-up form for updates about the program ■ 16 References • https:/ / institute.j pmorganchase.com/ institute/ research/ healthcare/ report-affording- healthcare#finding-6 • “ 2016 Medicine Use and S pending in the U.S .,” IQVIA • Federal Food Drug and Cosmetic Act (FDCA), S ection 804 • Colorado S enate Bill 19-005 https:/ / leg.colorado.gov/ sites/ default/ files/ 2019a_005_signed.pdf • https:/ / uscode.house.gov/ view.xhtml? req=(title:21% 20section:384% 20edition:prelim) • https:/ / www.accessdata.fda.gov/ cder/ sb-drls/ topic2/ topic2/ da_01_02_0050.htm • https:/ / www.gao.gov/ assets/ 690/ 681689.pdf • http:/ / www.worldstopexports.com/ international-markets-for-imported-drugs-by-country/ • https:/ / www.fda.gov/ about-fda/ fda-basics/ fact-sheet-fda-glance • FDAimports.com • NAS HP (National Academy of Health S tate Policy) 17 7
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